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A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children

NCT00344305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-07-24

Study results available
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Summary

Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Trivalent influenza virus vaccine live, intranasal

A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Raburn Mallory, M.D. · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-01
Primary Completion
2006-07-01
Completion
2006-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00344305 on ClinicalTrials.gov